Companion Diagnostic Assays with NanoString
Development and validation strategies for companion diagnostic assays all start with an expert team. With direct pharmaceutical and regulatory expertise, the NanoString team's collective knowledge spans throughout each step of the companion diagnostic development process, creating a best-in-class cross-functional team.
- Translational Research expertise to discover and optimize biomarkers
- Dedicated companion diagnostics team, project managed under stringent design control guidelines
- Experienced in regulatory application and approval processes for IDE and PMA submissions
- Global capability to execute clinical study protocols worldwide
- Skilled commercial leadership with proven paths for reimbursement
- Meticulous manufacturing performed under ISO 13485 and GMP guidelines
To speak with someone from NanoString’s Companion Diagnostics Program, please contact us at CDx@nanostring.com.
Building on the Discoveries of our Customers with NanoString as a Platform of Choice from Discovery to Diagnostic Assay
Publications are a great source of pride both for our customers and for NanoString. Each and every new publication brings exciting promise that together we are one step closer to addressing the complex challenges of treating and ultimately curing cancer.
Prosigna Breast Cancer Prognostic Gene Signature Assay for use on the nCounter Dx Analysis System is 510(k) cleared for in vitro diagnostic use. See www.prosigna.com for Package Insert.
Our Pipeline of New Diagnostic Assays Under Development
The nCounter portfolio of signatures is rapidly expanding as our system becomes more widely used. Signatures that started in the research lab, such as PAM 50 and work done by the Lymphoma/Leukemia Molecular Profiling Project (LLMPP) for the treatment of Diffuse Large B-Cell Lymphoma (DLBCL), are powering companion diagnostic development, while many hundreds of publications with other cancer types are fueling future signature development.
Selected Customer Signatures Developed with nCounter® Technology
- Subtypes of Diffuse Large B-cell Lymphoma
- Prognosis in Hodgkin’s Lymphoma
- Subtypes of Medulloblastoma
- Transcriptional Signatures in Prostate Cancer
- miRNA for Endometriosis and Ovarian Cancer
Other Sources of Content:
- New biomarkers discovered using nCounter (Custom CodeSets, Panels, Vantage Assays for 3D Biology)
- Migration from other technology platforms (ie RNA seq, rtPCR, microarrays, etc)
1-seer.cancer.gov, 2-cancer.org, 3-lymphoma.org, 4-These NanoString assays for use on the nCounter Dx Analysis System and are for investigational use only. Companion diagnostic products under development are for investigational use only. Limited by United States law to investigational use.